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RABEPRAZOLE
Rabeprazole is a marketed drug primarily indicated for the healing of erosive or ulcerative GERD. Its key composition patent is set to expire in 2028, providing a clear period of exclusivity. The primary risk is the potential increase in competition following the patent expiry.
At a glance
| Generic name | RABEPRAZOLE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1999 |
Approved indications
- Healing of Erosive or Ulcerative GERD
- Maintenance of Healing of Erosive or Ulcerative GERD
- Treatment of Symptomatic GERD
- Healing of Duodenal Ulcers
- Helicobacter pylori Eradication
- Treatment of Pathological Hypersecretory Conditions
- Treatment of Symptomatic GERD in Adolescents
Common side effects
- pain
- pharyngitis
- flatulence
- infection
- constipation
- diarrhea
- nausea
- vomiting
- abdominal pain
- headache
- taste perversion
- jaundice
Drug interactions
- Antiretrovirals (e.g., rilpivirine, atazanavir, nelfinavir)
- Antiretrovirals (e.g., saquinavir)
- Warfarin
- Methotrexate
- Digoxin
Key clinical trials
- Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib (PHASE1)
- Effect of ZaStaprazan on Platelet Reactivity of Clopidogrel After PercuTaneous CoronAry InteRvention (PHASE4)
- A Study to Evaluate the Effect of Food and Proton Pump Inhibitor on the Pharmacokinetics of ZN-A-1041 in Healthy Participants (PHASE1)
- The Impact of Helicobacter Pylori Eradication on the Vaginal Microecology Change
- Yiwei Jiaohuang Ointment for Gastrointestinal Bleeding Associated With Oral Antithrombotic Agents (EARLY_PHASE1)
- Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy and Bismuth Quadruple Therapy (NA)
- Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy, Vonoprazan-amoxicillin Dual Therapy and Proton Pump Inhibitor-based Standard Triple Therapy for Hp Eradication (NA)
- Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- RABEPRAZOLE CI brief — competitive landscape report
- RABEPRAZOLE updates RSS · CI watch RSS